Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- House Brackmann Grading System (HB)
研究概览
简要总结
Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.
详细描述
This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).
Clinical outcome measure comprised the House-Brackmann grading system, Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.
排除标准
- •Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
- •Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.
研究组 & 干预措施
Laser acupuncture Group
干预措施: Laser acupuncture (Device)
Laser acupuncture Group
干预措施: Steroids (Drug)
Sham laser acupuncture Group
干预措施: Steroids (Drug)
Sham laser acupuncture Group
干预措施: Sham laser acupuncture (Device)
Control group
干预措施: Steroids (Drug)
结局指标
主要结局
House Brackmann Grading System (HB)
时间窗: Baseline, weeks 2, 4, 6, 8, 12 and 24
The HB is a physician-rated system based on criteria of resting appearance, facial movements, and synkinesis that categorizes facial function from I (normal) to VI (total paralysis), with options of "Normal", "Mild dysfunction", "Moderate dysfunction", "Moderately severe dysfunction", "Severe dysfunction" or "Total paralysis". The prognoses of grade 3 or higher were abnormal.
次要结局
- Sunnybrook Facial Grading Scale (SB Grading)(Baseline, weeks 2, 4, 6, 8, 12 and 24)
- Facial Disability Index (FDI)(Baseline, weeks 2, 4, 6, 8, 12 and 24)
- Facial Clinimetric Evaluation Scale (FaCE Scale)(Baseline, weeks 2, 4, 6, 8, 12 and 24)